News

---

Supply issues flagged as TGA provisionally approves Moderna for under-fives

---

This article was updated at 4.40 pm on 19 July to include comments from the Federal Health Minister and infectious diseases paediatrician Professor Robert Booy.

Federal Health Minister Mark Butler has warned the public that Moderna’s paediatric vaccine is in short supply globally, hours after it was provisionally approved by the Therapeutic Goods Administration (TGA) for use in Australian children aged six months to five years.
 
Despite receiving TGA approval, Minister Butler told reporters much still needs to be done before the vaccine becomes available for very young children, including an assessment by the Australian Technical Advisory Group on Immunisation (ATAGI).
 
‘I want to stress again that there is very limited supply of this Moderna product, which is a different product to [those] made available to other age cohorts,’ he said.
 
‘As you can imagine, there is fierce competition by countries in North America, Europe and other parts of the world to get their hands on this very limited supply.
 
‘My department is in active negotiations right now with Moderna for Australia to secure as many doses as we possibly can.’
 
TGA provisional approval is the ‘first step’ towards the use of a COVID-19 vaccine in Australia, and indicates that the regulator has judged that it meets high safety, quality and efficacy standards.
 
The vaccine is the first to be approved for this age cohort in Australia, although it received a green light from the US Food and Drug Administration (FDA) last month.
 
In light of the global competition for supply, Minister Butler asked that parents delay booking in their very young children for a COVID vaccine until further notice.
 
‘There is no action yet that can be taken by parents … to make an appointment or otherwise,’ he said.
 
‘If I had a message to parents of children under the age of five today, it is to consider getting your child vaccinated for flu.
 
‘Our vaccination rates for influenza for under five-year-olds are lagging where they historically have been at this point in the flu season – lagging quite considerably.’
 
Minister Butler added that of the approximately 1300 Australians hospitalised due to influenza this flu season, more than 700 have been children under the age of 16.
 
Professor Robert Booy, an infectious diseases paediatrician who is also Head of the Clinical Research team at the National Centre for Immunisation Research and Surveillance, says the new vaccine is likely to be of most benefit for children who have multiple disabilities, chronic medical disorders, or immunodeficiency.
 
‘Having a new, safe product that can be given to children as young as six months is important,’ he said. 
 
‘Very young children can also transmit infections they catch at daycare, to their vulnerable parents, to teachers, and to vulnerable grandparents. 
 
‘Children who are otherwise well are unlikely to get severe COVID-19, but with vaccination, the risk goes down even more.’
 
Professor Booy also pointed out that safety reports from the US – where the new vaccine has already been used in hundreds of thousands of children – are ‘reassuring’.
 
‘The immune response from this vaccine in young kids is very similar to the immune response in older children, teenagers and young adults, even though the dose given is lower,’ he said.
 
‘The use of the Moderna vaccine for young children is likely to be both safe and effective, and implementation in Australia will contribute to better control of a disease that is proving elusive to manage.’
 
According to the TGA, Moderna’s paediatric vaccine is made in the same way as the vaccines for older people, but contains a lower concentration of the active ingredient:
 

• six months to less than five years – 25 mg in 0.25ml vial
• 6–11 years – 50 mg in 0.25ml vial
• 12 years and older – 100 mg in 0.5ml vial

 
As with other age groups, the TGA indicated the vaccine will be administered as two doses at least 28 days apart.
 
‘As we have seen with children in older age groups, the TGA expects that vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalisation and death,’ the release stated.
 
‘In making this regulatory decision, the TGA carefully considered data from the KidCOVE clinical trial, which was conducted at multiple sites throughout Canada and the United States and included over 6000 participants aged six months up to six years.
 
‘The study demonstrated that the immune response to the vaccine in children was similar to that seen in young adults [18–25 years] with a favourable safety profile.’
 
The TGA stated that most adverse events seen in clinical trials for this cohort were mild-to-moderate and generally reported after the second dose. Adverse events included irritability/crying, redness and/or swelling at injection site, fatigue, fever, muscle pain and axillary (groin) swelling or tenderness.
 
Provisional approval of this vaccine in this age group is valid for two years and subject to certain strict conditions, such as the requirement for Moderna to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
 
‘Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard,’ the regulator stated.
 
‘The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
 
‘The TGA will continue to actively monitor the safety of the vaccine in children and adults both in Australia and through collaboration with our overseas counterparts. If safety concerns are identified, we will take action and promptly provide information to the public.’
 
The TGA will publish the Australian Public Assessment Report relating to its provisional approval of the Moderna paediatric vaccine ‘in the coming days’.
 
Pfizer also recently began the process of applying for approval to use its own COVID-19 vaccine among the youngest age cohort in Australia.
 
Log in below to join the conversation

---

---

COVID-19 vaccine Moderna paediatrics TGA

---